With the widespread prevalence of venereal disease and the growing occurrence of AIDS (acquired immune deficiency syndrome), there is an increasing need for effective means to prevent the transmission of such diseases through sexual contact and resultant exchange of bodily fluids between a user and the user's partner.
Heretofore, conventional means for preventing the transmission of such bodily fluids and exposure to such diseases because of bodily contact have included the use of condoms, jells, creams and the like.
Additionally, there have been proposals to provide female prophylactic devices, which can be worn by a female prior to use and disposed of following use. While such conventional and proposed devices are suitable for their intended purpose, it has been found that they are not totally effective for various reasons.
One example of a prior prophylactic device for use by females is that set forth in U.S. Pat. No. 3,536,066. The '066 patent shows a pant styled garment having a bellow configured pouch thereon which is located on the exterior of the pant. The bellows is preinsertable into the vaginal canal of a female prior to use. After the bellows is inserted, convolutions therein are extended to provide for extension of the bellows to accommodate an erected penis during use of the contraceptive device. The device requires preinsertion of a segment of the bellows and does not include means for piloting a large pouch-like member into a vaginal canal or means for holding such a member in place. Furthermore, the garment portions of the device are formed from rubber material which is configured to contact a large portion of the waist region of the user as well as the buttocks and hip regions of a user so as to cause possible irritation and discomfort when worn for substantial periods of time prior to use.
U.S. Pat. Des. No. 254,809 to Meldahl discloses a device for use as a male contraceptive. While the contraceptive has a larger diameter than typical condoms, it does not include a portion thereon which will serve as the device to prevent the passage of bodily fluids between a user and a partner. There are not straps to hold the device in place.
Swiss Patentschrift No. 117,234 (1925) discloses a female contraceptive device having a pouch that includes a generally circular collar on the other end thereof. There is no suggestion to provide a portion of the device that will cover and conform to the full perineum region of a user. Furthermore, there is no suggestion of how to hold the device in place during use. Furthermore, the outer lip or collar of the condom can enter the vagina during intercourse so as to cause undesirable exposure of the users to the other's bodily fluids.
U.S. Pat. No. 4,735,621 likewise shows a thin walled, condomlike, tubular protective device for insertion into a vaginal canal. It includes a resilient ring on one end thereof to anchor the device in the vaginal canal.
The retention ring of the '621 patent is an integral part of the condom which requires special manufacturing tooling. Furthermore, the retention ring is configured to have a diameter corresponding to that of the pouch and a cross-sectional diameter that is small compared to the diameter of the ring. As a consequence the ring requires careful placement within the vagina so as to assure that it will fit in an interference relationship therewith to prevent the pouch from being withdrawn during coitus. Furthermore, the '621 retention ring may be oriented in a direction that will produce undesirable contact with an erected penis, i.e., causing pain during intercourse. Furthermore, the outer ring goes into the vagina during intercourse causing undesirable exposure of the users to bodily fluids.
Other female condoms have been proposed that include an internally located resilient insert element for holding the pouch portion of the female condom in place. One example is set forth in PCT International Publication No. WO90/00038 wherein an insert can be directed into the closed end of the pouch portion of the female condom. In this application, the insert is an absorbent and flexible expanded plastic material that includes spermicides or antiviral agents. The female condom in this case requires the use of a special insert and an applicator for performing the deployment of the female condom into its deployed position within a user.
Another example of a female condom having an interiorly located retainer element is set forth in U.S. Pat. No. 5,325,871 that discloses the use of an insertable retention member that can be compressed during insertion and that will, following deployment of the female condom into its deployed position, serve both as a radially outwardly directed retention pressure device as well as a device for dispensing spermicides, fungicides or the like.
While suitable for their intended purposes, such aforesaid devices have been found to lack an ease of application that will make the female condom acceptable and convenient to most users.
A counterpart to PCT No. WO/00038 is U.S. Pat. No. 5,193,555. As shown in FIG. 1 this invention requires use of an insertion tool 15. Another female condom requiring an insertion tool is shown in U.S. Pat. No. 5,146,930. In the '555 patent retention is provided by a multi-fingered insert with a central portion and a radially outwardly directed portion that springs out following tool insertion for holding the condom pouch in place. In the '930 patent retention is provided by a series of flexible protrusions that are on the outside of the pouch and that are inclined in a direction to prevent pull-out of the pouch. In both the '555 and '930 patent the pouch is connected to a shield that is arranged around the opening to the pouch and the pouch opening is located generally centrally of a thicker shield having an enlarged portion that holds the pouch opening centered while covering the entrance to the vagina.
While such condoms provide protection and cover the perineum of a user they are difficult to insert into the user and are uncomfortable if kept in place during walking and the like since the outer thicker shield is continuously spread open to keep the pouch opening centered with respect to the shield surface. All of the above condoms reduce pleasure to one or both partners during intercourse.
Accordingly, another feature of the present invention is to provide an easily inserted female condom that includes a pouch that has an extension thereon having the same wall thickness as the pouch and is configured to laterally collapse and expand freely to accommodate user movements. The arrangement does not require a separate thicker shield member arranged in a spread position to center the pouch opening with respect to the shield.
In the embodiment of FIG. 1, the shield portion is formed of the same wall thickness as that of the pouch and is arranged to easily collapse laterally. As a consequence, once inserted in place, the shield will, because of a thin wall having a thickness range of 0.02 mm to 0.06 mm, will enable the front and rear walls to easily move laterally to accommodate user movement.
Still another problem with female condoms is the fact that they can interfere with pleasurable coitus. Thus, in accordance with another aspect of the invention sponge fillers are provided on the pouch on either side thereof closely adjacent the shield for filling any gaps between the vaginal wall and to form a tight opening for penal insertion in the vicinity of the clitoris for providing stimulation to both male and female users of the female condom.
Still another problem with female condoms is that of accidental withdrawal and leakage from the female condom. Thus, in accordance with still another aspect of the present invention, a second premolded thin member is heat sealed to a shield on the open end of the female condom to provide a labyrinth seal against leakage from the interior of the female condom and to provide a directional guide into the interior of the female condom while providing an extension on the end of the female condom that will deploy automatically to prevent inadvertent withdrawal.